Clinical Investigation to Assess Safety and Efficacy of INNEA AQUA in Adult Women With Vulvo-Vaginal Atrophy (VVA)

NCT07367061 | Active Not Recruiting

• 1 other identifier: INN-AQA-10/24
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 3

Brief Summary

Clinical investigation to assess safety and efficacy of INNEA AQUA in adult women with Vulvo-Vaginal Atrophy (VVA). To assess the Safety and efficacy of INNEA AQUA

Conditions

Vulvo Vaginal Atrophy

Keywords

VVA; hyaluronic acid; vulvo vaginal atrophy; vaginal atrophy

Outcome Measures

Primary Outcomes (1)

• safety: Incidence of AE and SAE

  To evaluate the safety of INNEA AQUA in adult participants. Incidence of adverse events, early withdrawal rate due to AEs, and device deficiencies, whether serious or not

  From enrollment to the end of treatment and second follow up visit at 120 days from the first injection

Secondary Outcomes (12)

• Efficacy: change in pruritus

  From enrollment to the end of treatment and second follow up visit at 120 days from the first injection

• Efficacy: Change in soreness

  From enrollment to the end of treatment and second follow up visit at 120 days from the first injection

• Efficacy: change in dyspareunia

  From enrollment to the end of treatment and second follow up visit at 120 days from the first injection

• efficacy: change in irritation

  From enrollment to the end of treatment and second follow up visit at 120 days from the first injection

• efficacy: evaluation of pH

  From enrollment to the end of treatment and second follow up visit at 120 days from the first injection

Study Arms (2)

Arm 1: randomized to the treatment Innea Aqua

EXPERIMENTAL

31 women (18-75) treated with product Innea Aqua. 1 injection of the product and after 30 days another injection

Device: product: Innea Aqua vaginal use

Arm 2: randomized to the treatment to the standard of care

ACTIVE COMPARATOR

standard of care tratment

Device: arm 2: standard of care

Interventions

product: Innea Aqua vaginal use DEVICE

product object of the investigation: Innea Aqua for vaginal use, 2 mL product. Labelled as Innea Aqua.

Arm 1: randomized to the treatment Innea Aqua

arm 2: standard of care DEVICE

the comparator is the standard of care selected by the centre

Arm 2: randomized to the treatment to the standard of care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: female (18-75 Years old)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women aged 18-75 (both fertile and post-menopausal)
• Vulvovaginal atrophy diagnostic
• Signed written informed consent.
• Vaginal Ph more than 4.5
• Willing to sign the informed consent form
• Willing to comply with the clinical investigation visits.

You may not qualify if:

• patients who tend to develop hypertrophic scarring,
• patients with a history of autoimmune disease or who are receiving immune therapy,
• patients who are known to be hypersensitive or allergic to hyaluronic acid and other INNEA AQUA components,
• pregnant or breastfeeding women,
• patients under 18 years of age,
• vagina with hypertrophic scars from different etiology,
• patients with presence of ≥ stage 2 apical pelvic organ prolapse,
• patients with stress urinary incontinence,
• patients with vaginismus, vulvovaginal or urinary tract infection,
• patients with Hemorrhagic or neoplastic genital pathologies or hormone-dependent tumor
• patients with genital bleeding of unknown etiology, recurrent porphyria, uncontrolled epilepsy, heart conduction disorders, recurrent angina, rheumatic fever, previous vulvovaginal or uro-gynecological surgery, and hemostatic disorders,
• Anticoagulated patients or patients receiving platelet aggregation inhibitors should not be treated with INNEA AQUA,
• INNEA AQUA must not be used in areas presenting inflammatory and/or infectious processes (e.g., papilloma, herpes). INNEA AQUA must not be used in association with other invasive treatments,
• Avoid using in combination with any other concomitant therapies for same indication;
• Patients who are using substances that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may, as with any injection, experience increased bruising or bleeding at treatment sites.

Sponsors & Collaborators

• Innate srl: lead
• CEBIS International: collaborator

Study Sites (3)

Obstretics and Gynaecology Filantropia Clinical Hospital

Bucharest, Romania, 011132, Romania

Location

Nicolae Malaxa Clinical Hospital

Bucharest, Romania, 022441, Romania

Location

AMCA Medical Clinic

Bucharest, Romania, 030863, Romania

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open, double-arm, prospective, multicenter clinical investigation to evaluate the safety and efficacy of INNEA AQUA in adult women aged 18-75 with Vulvo-vaginal atrophy (VVA). The enrollment period will be 6 months, and the clinical investigation period will be up to 12 weeks per patient.

Study Record Dates

• First Submitted: January 17, 2026
• First Posted: January 26, 2026
• Study Start: September 25, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

RO (3)